Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharmaceutical, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
This is a study for people diagnosed with hypertension to compare the safety and
effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in
the study for 12 weeks.
Clinical Details
Official title: A Twelve-week, Randomized, Double-blind, Parallel-group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Atenolol in Patients With Essential Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Change from baseline in diastolic blood pressure after 12 weeks
Secondary outcome: Change from baseline in systolic blood pressure after 12 weeksDiastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 12 weeks Blood pressure of < 140/90 mmHg after 12 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Outpatients 18 years of age and older.
2. Patients with essential hypertension.
Exclusion Criteria:
Severe hypertension, Current diagnosis of heart failure, History or evidence of a
secondary form of hypertension, Participation in any investigational drug study within one
month of planned participation,
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Investigative Centers, Germany
Novartis, Basel, Switzerland
Additional Information
Starting date: November 2005
Last updated: November 7, 2011
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